HPLC法测定5-单硝酸异山梨酯渗透泵片含量

目的: 建立5-单硝酸异山梨酯渗透泵片含量测定的高效液相色谱法。 方法: 采用Agela Venusil MP C₁₈ (5 μm,4.6 mm×150 mm),以甲醇-水(20∶ 80)为流动相,流速为1.0 mL · min^-1,检测波长为210 nm。 结果: 在49.60~148.80 μg·mL^-1范围内,峰面积与浓度线性关系良好,r=0.9996 (n=5);方法的平均回收率为99.1%,其RSD为0.42%;重复性试验的RSD为0.86% (n=9)。 结论: 该方法准确可靠,专属性强,能满足制剂质量控制的要求。

Objective: To establish a method of determination the content of isosorbide 5-mononitrate osmotic pump tablets by HPLC. Method: The Agela Venusil MP C₁₈column (5 μm,4.6 mm×150 mm) was adopted,methanol-water(20∶ 80)as the mobile phase,at a flow rate of 1.0 mL · min^-1,at detection wavelength 210 nm. Results: The linearity of peak area was good when the concentration was in the range of 49.60-148.80 μg·mL^-1.The average recoveries was 99.1%,the relative standard deviation(RSD)was 0.42%,the RSD of the repetability was 0.86%,(n=9). Conclusion: The method is accurate,reliable,specific and convenient,which can be used for quality control of isosorbide 5-mononitrate osmotic pump tablets.